DODIA 1

Screening for diabetic retinopathy: the first telemedical approach in a primary care setting in France (DODIA study).

EPGRN, Nijmegen, May 11th, 2007

J.P. Aubert, P Massin, S. Bouée, G. Audran, A. Ben Mehidi, B Bernit, M Bouhassira, JC Bourovitch, I Cahitte, E.Eschwege, F.

Fagnani, M. Marre, M Nougairède,AM Simonpoli

BACKGROUND

main cause for blindness in the working population

easily preventable :screening+laser In France, screening for DR is recommended

once a year for all diabetic people

BACKGROUND

2.000.000 diabetics inFrance, increasing 5% every year 30 to 40% of french diabetics are expected to have a DR 41,5 % of diabetics had been examined by an

ophtalmologist within the last year 5000 ophtalmologists in France in 2005, 2500 will remain in 2015 DR screening has to be optimized

SCREENING METHODS

Conventionnal screening: eye fundus examination after pupillary dilatation

Colour fundus photography obtained without pharmacological dilatation of the pupil storage and electronic transmission of

photographs is easy

Eye fundus photography

3 photographs: papilla, macula, and temporal area.

Sensitivity 85%, specificity 95%

Study design

Observationnal study with control group

experimental group: GPs from the Réseau de Santé Paris-Nord (North Paris Health network).

control group : GPs from ARES-92 (another health network of the Paris suburb)

All investigators were volunteer

control group close geographic location to the experimental group, similar density of private ophthalmologists in the area, similar social and demographic characteristics of the living population.

Management of the experimental group

non-mydriatic camera was set up in a community screening center,

Patients referred by GPs to the screening center for photography of eye fundus

Electronic transmission to Hospital Lariboisiere, Paris Postponed interpretation of photographs by

ophtamologists (15 to 20 patients an hour) Results sent by snailmail to GP and patient

Management of the control group

Usual procedure: Patients referred to their ophtalmologist Usual eye fond examination performed

Primary endpoint

To assess the rate of actual DR screening among diabetic patients (type 1 and 2) from the two investigators groups

Secondary endpoints

Improvement of the GP’s knowledge of retinian

condition of their patients

satisfaction and compliance of patients regarding

the photographic screening method

rate of patients that accept the photographic

screening method

NB: no assessment of the efficiency of screening

What do we call « screening »?

A screening for DR is an examination of eye fundus perfomed within six months after prescription by the GP, testified by the presence of a written report in the patient’s file.

Inclusion/exclusion criteria

All type 1 and 2 diabetic patients attending one of the investigators during the inclusion period (7 months 1.4.2002-1.11.2002)

Were excluded: Patients with known DR Patients who had had screening for DR within last year Patients from the experimental group who asked to consult their

usual ophtalmologist People who refused the study

Participation of investigators

Experimental group

Control group

GPs contacted for the study

192 438

GP who accepted the study

104 (54,2%) 93 (21,2%)

GP who included patients

68 (65,4%) 53 (57%)

Patients

Experimental group: 667 screened patients, 519 (78%) met inclusion criteria, of which 456 (87,9%) accepted the study

Control group: 707 screened patients, 469( 67%) met inclusion criteria, of which 426 (90,8%) accepted the study

Baseline characteristics of patients

No stastistical difference regarding

Gender: 2/3 male Mean age: 60 Haemoglobin A1c (when available): 7,7% Mean blood pressure Treatment for diabetes (77,2% oral treatment alone) History of eye fundus examination (more than one year): 85%

diabetes discovered more recently in the experimental group (6.4 ± 6.6 years vs 8.1 ± 8.0, p = 0.0011)

apatients more frequently treated with diet alone in the experimental group (12.6% vs 7,9%, P = 0.002).

Primary outcome

Intervention Control p included 456 426 Not lost to follow-up

417 (91,4%) 417 (97,9%)

Presence of screening report in the patient’s file at 6 months

309 (74,1%) 298 (71,5%)

No screening report in the patient’s file

108 (25,9%) 119 (28,5%)

NS

Screening results

Intervention (n= 309)

Control (n= 298)

p

No DR 244 (79 %) 267 (89,6 %) <0,001 DR 49 (15,9 %) 31 (10,4 %) 0,009 Proliferative DR 0 4 Non proliferative DR

49 18

Not detailed 0 9 Not gradable 16 (5,1 %)

(dont 6 cataractes)

0

Cataract 12 (3,9 %) 16 (5,4 %) Others 10 (3,2 %) 20 (6,7 %)

The delay before appointment is…(p<0,001)

10%1%

24%

99%

66%

0%

20%

40%

60%

80%

100%

rétinographe témoin

acceptable

long

très long

I experienced visual impairment due to screening (p<0,001)

59%

24%

27%

42%

13%

27%

2% 8%

0%

20%

40%

60%

80%

100%

rétinographe témoin

très gêné

assez gêné

peu gêné

pas du toutgêné

The place for screening is easy to reach (p<0,001)

1% 3%

16%4%

10%22%

72% 71%

0%

20%

40%

60%

80%

100%

rétinographe témoin

pas difficile

peu difficile

difficile

très difficile

I had to wait in the screening place (p<0,001)

99%

76%

1%

21%

3%

0%

20%

40%

60%

80%

100%

rétinographe témoin

très long

peu long

acceptable

The duration of the test (p<0,001)

96%82%

4%17%

2%

0%

20%

40%

60%

80%

100%

rétinographe témoin

très long

peu long

acceptable

Conclusion digital retinal images taken in a screening center and transferred

electronically to an ophthalmologic detects and grades DR in primary care patients, filters eye-threatening cases requiring complete eye analysis by

an ophthalmologist. The screening procedure is effective, increasing GPs’awareness

about their patient’ eye status. Most patients who received non dilated eye fundus photographs

are satisfied need to extend this screening program to a larger number of

different French sites.

2006: toujours plus loin Fort de l’étude DODIA, le Réseau de santé Paris

Nord a poursuivi son travail:

Les OPH achètent massivement des rétinographes, dont le prix a baissé considérablement

L’examen au rétinographe est devenu le gold standard de la rétinopathie diabétique

Le réseau a fabriqué la première banque de données photographiques européenne de dépistage de la rétinopathie diabétique

Le réseau a mis au point un outil de formation des OPH, mis en ligne et qui va être annexé aux recommandations françaises de dépistage de la RD

Sources utilisées dans cette présentation [1] Klein R, Klein BEK, Moss SE, Davis MD, DeMets DL. The Wisconsin Epidemiologic Study of Diabetic

Retinopathy : II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol 1984 ; 102 : 520-526.

[2] Klein R, Klein BEK, Moss SE, Davis MD, Demets DL. The Wisconsin Epidemiologic Study of Diabetic Retinopathy : III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 years or more. Arch Ophthalmol 1984 ; 102 : 527-532.

[3] Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology 1991 ; 98 : 766-785.

[4] Massin P, Angioi-Duprez K, Bacin F, et al. Recommandations de l'ALFEDIAM pour le dépistage et la surveillance de la rétinopathie diabétique. Diabète et Métabolisme 1996 ; 22 : 203-209.

[5] Recommandations de l'ANAES. Suivi du patient diabétique de type 2 à l'exclusion du suivi des complications. Complications oculaires. Doiabète Metab 1999 ; 2( suppl) : 35-38.

[6] Detournay B, Vauzelle-Kervroedan F, Charles MA, Forhan A, Fagnani F, Fender P, Eschwege E. Epidémiologie, prise en charge et coût du diabète de type 2 en France en 1998. Diabetes Metab 1999; 25(4) : 356-65.

[7] Massin P, Erginay A, Ben Mehidi A, Vicaut E, Quentel G, Victor Z, Marre M, Guillausseau PJ, Gaudric A   Evaluation of a new non-mydriatic digital camera for detection of diabetic retinopathy.  Diabet Med. 2003 Aug;20(8):635-41.